Sarns Ultrasonic Air Sensor
FDA 510(k) K940651 · 3M Health Care, Sarns
510(k) numberK940651
Submission
- Device name
- Sarns Ultrasonic Air Sensor
- Applicant
- 3M Health Care, Sarns
Ann Arbor, MI, US - Received
- February 15, 1994
- Decision date
- May 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRL – Detector, Bubble, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4205
- Specialty
- Cardiovascular
Other 510(k)s with product code KRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K103469 | Stockert Air Purge Control System Model 23-45-05KRL · Traditional | Sorin Group Deutschland GmbH | 01/18/2011SE |
| K090698 | Capiox Bubble Trap with X-CoatingKRL · Traditional | Terumo Cardiovascular Systems | 06/08/2009SE |
| K071231 | Edac QuantifierKRL · Traditional | Luna Innovations, Inc. | 05/17/2007SE |
| K961364 | Automatic Tubing Clamp System (Atc)KRL · Traditional | Rocky Mountain Research, Inc. | 10/31/1996SE |
| K961598 | Els Automatic Tubing Clamp SystemKRL · Traditional | Rocky Mountain Research, Inc. | 10/29/1996SE |
| K935977 | Sarns Air Detection SystemKRL · Traditional | 3M Health Care, Sarns | 02/04/1994SE |
| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/18/1993SE |
| K925541 | Stockert 1/4 Bubble SensorKRL · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 02/02/1993SE |
| K911632 | Capiox(R) Bubble TrapKRL · Traditional | Terumo Medical Corp. | 07/09/1991SE |
| K864619 | Caps Low Level Detector & Detector/Bubble MonitorKRL · Traditional | Shiley, Inc. | 02/03/1987SE |
More from Shiley, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960916 | Sams 8000 Cardioplegia MonitorDSJ · Traditional | 06/04/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 04/19/1996SE |
| K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion SystemDWA · Traditional | 11/17/1995SE |
| K941653 | Sarns Turbo Membrane Oxygenator ModificationDTZ · Traditional | 08/24/1994SE |
| K941654 | Sarns Filtered Venous Reservior ModificationDTP · Traditional | 07/26/1994SE |
| K935391 | Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional | 02/24/1994SE |
| K934127 | Sarns Low Jetting Aortic Arch CannulaDWF · Traditional | 02/22/1994SE |
| K935977 | Sarns Air Detection SystemKRL · Traditional | 02/04/1994SE |
| K915547 | Sarns 8000 Delphin II Centri Pump Mod W/Integr BatKFM · Traditional | 09/09/1993SE |
| K925076 | Sarns Turbo Membrane Oxygena. W/Int. Cardiotomy R.DTZ · Traditional | 06/07/1993SE |
Questions and answers
When was Sarns Ultrasonic Air Sensor cleared by the FDA?
Sarns Ultrasonic Air Sensor (K940651) received a 510(k) decision of Substantially Equivalent on May 24, 1994, 98 days after the submission was received.
What is the product code of K940651?
The FDA product code is KRL – Detector, Bubble, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4205.